FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
02/19/1992
Recalls and Field Corrections: February 19, 1992
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
product will cause serious adverse health consequences or
death.
Product: Smoked Salmon in clear plastic vacuum packages.
Recall #F-118-2.
Code: 364006.
Manufacturer: Beach Smokehouse, Virginia Beach, Virginia.
Recalled by: Manufacturer, by telephone December 20, 1991. Firm-
initiated recall complete.
Distribution: Virginia.
Quantity: 67.28 pounds were distributed.
Reason: Product is contaminated with Listeria monocytogenes.
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Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Meperidine Hydrochloride Injection, USP, 25 mg/ml, in
1 ml vials, a Rx narcotic analgesic. Recall #D-213-2.
Code: Lot #061154 EXP 3/93.
Manufacturer: Elkins-Sinn, Inc., Cherry Hill, New Jersey.
Recalled by: Manufacturer, by letter dated January 20, 1992. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates 68,766 vials remain on the market.
Reason: A vial of Meperidine was found mislabeled as Robinul
Injection.
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Product: Platelets. Recall #B-134-2.
Code: Unit #8220518.
Manufacturer: The Blood Center for Southeast Louisiana, New Orleans,
Louisiana.
Recalled by: Manufacturer, by facsimile on October 25, 1991. Firm-
initiated recall ongoing.
Distribution: Florida.
Quantity: 1 unit.
Reason: Blood product which tested repeatably reactive for
the hepatitis B surface antigen (HBsAg), was distributed
for use in further manufacturing.
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Class III -
Product: Digoxin Tablets, USP, 0.25 mg, in bottles 1000 and
5000 tablets, a Rx drug under the following labels:
Zenith, Aligen, Best Generics, Bioline, Dixon Shane,
Goldline, Glenlawn, H.L. Moore Drug Exchange, Interstate
Drug Exchange, Rugby, Schein, United Research Laboratories.
Recall #D-212-2.
Code: All lots.
Manufacturer: Zenith Laboratories, Inc., Northvale, New Jersey.
Recalled by: Manufacturer, by letter dated July 17, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates 487 bottles of 1,000 tablets and
50 bottles of 5,000 tablets remain on the market.
Reason: Product does not meet dissolution specifications.
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Product: Platelets. Recall #B-132-2.
Code: Unit numbers: 0143277 through 0143296, 0143301 through
0143312, 0143314 through 0143318, 0146527 through 0146533,
0146536, 0146539, 0146541 through 0146546, 9006267,
9006268, 9006269.
Manufacturer: Blood Bank of Delaware, Inc., Newark, Delaware.
Recalled by: Manufacturer, by telephone July 9, 1991, followed by
letter July 15, 1991. Firm-initiated recall complete.
Distribution: Delaware.
Quantity: 55 units.
Reason: Platelets stored under unacceptable temperatures were
distributed.
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Product: Fresh Frozen Plasma. Recall #B-133-2.
Code: Unit numbers: 5313164-1, 5313164-3, 7010671-1, 7012001-1.
Manufacturer: J.K. & Susie Wadley Research Institute and Blood Bank,
Dallas, Texas.
Recalled by: Consignee telephoned firm May 29, 1991. Recall complete.
Distribution: Pennsylvania, Virginia.
Quantity: 4 units.
Reason: Blood products unlicensed and without expiration dates
were distributed in interstate commerce.
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DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Fragmentation needles:
(a) MVS 1600A, Fragmentation Needle 15 Degree for Paraxial,
packaged individually;
(b) MVS 10601A, Fragmentation Needle 60 Degree for Paraxial,
packaged individually. Products are for use in ophthalmic
surgery. Recall #Z-318/319-2.
Code: Lot numbers: 91154 through 91278.
Manufacturer: Lake Region, Chaska, Minnesota (contract manufacturer).
Recalled by: Storz Instrument Company, St. Louis, Missouri, by
letter November 21, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 622 packages were distributed.
Reason: The needle may break off from the hub.
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Class III -
VETERINARY PRODUCTS
NONE
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Seizure Action Filed:
Product: Royal Jelly Products (91-638-640).
Charge: Products are unapproved new drugs;
Misbranded - The product's labeling lacks adequate
directions for their safe and effective use.
Firm: Bee Alive, Inc., Valley Cottage, New York.
Filed: January 10, 1992 - U.S. District Court for the Southern
District of New York; Civil #91-CIV-0190, FDC #66269.
Seized: February 4, 1992; various Royal Jelly Products valued
at approximately $160,000.
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